Status of Import License (Form 10) of Recombinant Products, Human and Veterinary Vaccines issued from 01/01/2017 to 31/12/2017

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1 1. M/s Zuventus Healthcare Limited Office No. 5119,5 th Floor, Oberoi Garden Estate, Chandivali, Andheri (East) Mumbai, Tal: Sakinaka (Mumbai -Zone 4) Pin: M/s. Shantha Biotechnics Limited, Survey No.274, Athveli Village, Medchal Mandal , Hyderabad, Andhra Pradesh, 3. M/s. GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road,Worli, Mumbai , Maharashtra,. HUMAN VACCINE Varicella Vaccine, Live I.P. (Oka Strain) Lyophilized milky white powder for injection in a single dose vial for Subcutaneous administration. Each single dose (0.5ml) after reconstituted with diluent contains: Name of Ingredients Active Ingredients Varicella-Zoster Virus Live attenuated (Oka Strain) Quantity 2000 plaque forming units (PFU) SV Sterile Water for Injection as Diluent- 0.6ml Inactivated Vero Trivalent Poliovaccine Bulk (Concentrated Trivalent) SVH Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B (rdna), Inactivated Poliomyelitis and Haemophilus influenza type b conjugate vaccine (adsorbed) [(DTaP-HBV-IPV) + Hib]Vaccine Dosage Form- Component I: A turbid suspension for Injection in a pre-filled syringe containing Diphtheria, Tetanus, Acellular Pertusis, Hepatitis B (rdna) and Inactivated Poliomyelitis (DTaP-HBV-IPV). Component II: Lyophilized white powder of Haemophilus influenza type b (Hib) in a glass vial. (Reconstitution is done by adding the entire contents of the supplied container of the DTPa-HBV-IPV liquid component I to the vial containing the lyophilized adsorbed Hib component-ii). 31/07/2020 SV /12/2017 Page 1 of 10

2 4. M/s Sanofi Pasteur Private Quadrivalent Inactivated Influenza Vaccine (Split Virion) I.P. SV Ltd. Sanofi House, CT Survey No. 117-B, L& T Business 31/12/2017 Park, Saki Vihar Road Powai, Mumbai M/s Wockhardt Limited Wockhardt Towers, Bandra Kurla Complex, Bandra (East), Mumbai , Maharashtra, Varicella Vaccine(Live)I.P., Freeze Dried along with sterile water for injection (as diluent) SV /07/ M/s G. C. Chemie Pharmie Ltd.,5/C, Shree Laxmi Industrial Estate,New Link Road, Andheri (West), Mumbai ,. 7. M/s GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road, Worli, Mumbai , Maharashtra 8. M/s GlaxomithKline Pharmaceuticals Ltd.,S.No. 14/4, Godown No 1 & 2, Each 0.5 ml Inactivated Influenza Vaccine (Split Virion) I.P., Suspension for injection in prefilled syringes contains: - an A/Michigan/45/2015 (H1N1) pdm µg - an A/Hong Kong/4801/2014 (H3N2) µg - a B/Brisbane/60/ µg Each 0.25 ml Inactivated Influenza Vaccine (Split Virion) I.P., Suspension for injection in prefilled syringes contains: - an A/Michigan/45/2015 (H1N1) pdm µg - an A/Hong Kong/4801/2014 (H3N2) µg - a B/Brisbane/60/ µg SV /08/2020 Meningococcal Group A, C, W-135 and Y Conjugate Vaccine SVH /08/2020 Quinvaxem (DTwP-Hip-HepB) vaccine SVH /01/2020 Page 2 of 10

3 Village Yavai, Near Water Filtration Plant, Bhiwandi, Dist. Thane , 9. M/s GlaxoSmithKline Pharmaceuticals Limited, Southern Portion of Ground and First Floor, No.144, Poonamallee High Road, Vellappanchavadi, Chennai-77 Rotavirus Vaccine (live attenuated, Oral) I.P Human Papillomavirus Vaccine r-dna Ph.Eur SV /12/ M/s Organon Pvt. Ltd.,Gala No. 1-C, Bldg No. B- 3, City Link, Ware housing Com. Mumbai Nashik Highway, Vadapa, Tal Bhiwandi, Dist - Thane M/s Sanofi Synthelabo () Private Limited, City Link Warehousing Complex, Bldg. No. 3,Gala No. 6A, S. No , Village Vadpe,Tal: Bhiwandi , Taluka: Bhiwandi-13 (Bhiwandi Corporation)(Thane Z5), Maharashtra RECOMBINANT PRODUCTS Follitropin Beta (FSH) solution for injection 50IU & 100 IU in Ampoules/Vials Follitropin Beta (FSH) solution for injection 300IU & 600 IU in Cartridges Imiglucerase for injection Powder for concentrate for solution for infusion-single use vial FF valid up to 31/10/2020 FF /09/2020 *Transfer of Import License from M/s Sandor Medicaids Pvt. Ltd., to M/s Sanofi Synthelabo () Private Limited, Page 3 of 10

4 3 M/s Bristol-Myers Squibb Belatacept 250mg/vial Lyophilized Powder for Intravenous infusion in 20 ml vial, FF Pvt. Ltd., Bldg. B-4, Gala No. 3, co- packaged with a silicon free disposable polypropylene Syringe. 4, 5A & 6A,City link Ware Nivolumab 10 mg/ml concentrate for solution for infusion for infusion, (r-dna 30/9/2020 Houses Complex, Mumbai origin). Nashik Highway,Vadpe Village Tal: Bhiwandi-16, District Thane-Z5 Pin M/s Dr. Reddy s Laboratories Ltd., Global Distribution Centre, Survey No. 41, Bachupally (V), Qutubullapur (M), Ranga Reddy District, Hyderabad , Telangana, Evolocumab solution for Injection 140mg/mL FFR /07/ M/s Vita Pharma Agencies, 305, Arenja Corner, Plot No. 71, Sector-17, Vashi, Navi Mumbai M/s Sanofi Synthelabo () Private Limited, Citylink Warehousing Complex, Bldg. No. 3, Gala No. 6A, S.No. 120, 121, Village Vadpe, Tal: Bhiwandi , Taluka: Bhiwandi-13 (Bhiwandi Corporation), District: Thane Z5, 7 M/s Eli Lilly and Company () Private Limited, Plot no. 92, Sector-32, Gurgaon Recombinant Human Erythropoietin solution for injection Each Prefilled syringe of 1ml injection contains: Recombinant Human Erythropoietin. 2000IU/ml, 3000 IU/ml, 4000 IU/ml Page 4 of 10 FFR /11/2019 Agalsidase beta Powder for concentrate for solution for infusion FF /01/2020 Dulaglutide (r-dna origin) Solution for injection Each pre-filled pen contains Dulaglutide 0.75mg/1.5mg Fill Volume:0.5ml (for both presentations) FFR /01/2018

5 Haryana, Presentation: In single use prefilled pen. 8 M/s Sanofi Synthelabo () Private Limited, Citylink Warehousing Complex, Bldg. No. 3, Gala No. 6A, S.No. 120, 121, Village Vadpe, Tal: Bhiwandi , Taluka: Bhiwandi-13 (Bhiwandi Corporation), District: Thane Z5, Maharashtra 9 M/s Sanofi Limited, Gala No. 3,4,5,6B& 6C, 7F, City Link Warehousing Complex Building No. B3, S.No ,Vill. VadpeBhiwandi- Thane , Maharashtra, 10 M/s Sanofi Synthelabo () Private Limited, Citylink Warehousing Complex, Bldg. No. 3, Gala No. 6A, S.No. 120, 121, Village Vadpe, Tal: Bhiwandi , Taluka: Bhiwandi-13 (Bhiwandi Corporation), District: Thane Z5, 11 M/s Sanofi Synthelabo () Private Limited, Citylink Warehousing Complex, Bldg. No. 3, Gala No. 6A, S.No. 120, Laronidase for solution for Injection FFR /01/2020 Insulin Glargine 300U/ml (as Solostar Penfilled Pen 1.5ml cartridges)(monocomponent Insulin Glargine) Aglucosidase alfa for Injection (r-dna Origin) Lyophilized Powder for Concentrate for solution for Intravenous Infusion Thyrotropin Alfa Lyophilized Powder for Solution for Injection (for intramuscular use only) FF Valid upto 31/12/2017 FF /12/2019 FF /12/2019 Page 5 of 10

6 121, Village Vadpe, Tal: Bhiwandi , Taluka: Bhiwandi-13 (Bhiwandi Corporation), District: Thane Z5, 12 M/s. Boehringer Ingelheim Idarucizumab 2.5mg/50ml solution for injection/ infusion FF-88-6 Pvt. Ltd., Bld No.D-5, Gala no:1 to 3, Shree Arihant 28/02/2018 Compound, Ground Floor, Reti Bunder Road, Kalher, Bhiwandi, Tal: Bhiwandi 15 (Thane Zone 5) Pin: , Maharashtra,. 13 M/s Pfizer Products Private Limited., The Capital-B Wing, 1802, 18 th Floor, Plot No. C-70, G-Block, Bandra Kurla Complex, Bandra (East), Mumbai ,. 14 M/s Johnson & Johnson Private Limited, Gala No. 3, Bldg. No. B-2, Citylink Warehousing Complex, S.No , Munbai, Nashik Highway, Village Vadpe, Tal Bhiwandi-16 (Zone Z5) , 15 M/s Sun Pharmaceutical Industries Ltd., Tandalja, Vadodara ,. Recombinant Somatropin (Sterile, Lyophilized Powder) for solution for subcutaneous Injection; 5.3 mg (16 IU) and 12 mg (36 IU) with sterile diluents (m- Cresol-Mannitol-Water) for Injection Siltuximab powder for concentrate for solution for infusion 100 mg & 400 mg (r- DNA origin) Daratumumab concentrate for solution for Infusion 100mg and 400 mg FF /03/2020 FF /07/2018 Recombinant Human Growth Hormone for injection Ch.P. FFR /03/2020 Page 6 of 10

7 16 M/s Biocon Limited, Biocon Recombinant Human Insulin IP(rDNA origin)- Bulk is permitted for conversion into FFR Special Economic Zone, Plot insulin formulation meant for export purpose only. No. 2-4, Phase IV, 20/12/2019 Bommasandra- Jigani Link Road, Bommasandra Post, Bangalore ,. 17 M/S Novartis Limitd, Sandoz House, Shivsagar Estate Dr. Annie Besant Road,Worli Mumbai M/S Alcon Laboratories () Pvt. Ltd. 3 rd Floor, Cresent 4,Prestige Shantiniketan, Whitefiled Banglore,Pin:560048, Basiliximab Injection/I.V Infusion: Basiliximab-20 mg along with ampule of 5ml water for injection FF /12/2020 Ranibizumab Solution for injection(r-dna origin) 10mg/ml FFR Valid up to 16/11/ M/s Intervet Pvt. Ltd., Sagar Complex, Bldg B-1, Gala No. 12 to 14 Ovali Village, Bhiwandi, tal: Bhiwandi-16(Thane-Z5), Maharastra M/s Panav Bio-Tech, Shop No. 131, 1 st Floor, Vardhman Big V Plaza,Plot No. 12, C-Centre, Road No. 44, Rani Bagh, Pitampura, Delhi ,. VETERINARY VACCINES Combined Avian Infectious Bronchitis Vaccine and Ranikhet Disease Vaccine Live, I.P Combined Canine Distemper, Canine Contagious Hepatitis infectious laryngotracheitis, Canine Parvovirus & Canine Parainfluenza immunoglobulin Inactivated vaccine against Rabies Hyper Immune Heterogenous Immonoglobulins parvovirusis Polyvalent vaccine against distemper, infectious hepatitis, infectious Laryngotracheitidis, Parvovirosis, parainfluenza SV valid up to 31/12/2017 SV /05/2020 Page 7 of 10

8 and Leptospirosis for dogs, canids and stoats except ferrets Hyper Immune heterogeneous immunoglobulin against Distemper Bivalent Canine Distemper, Live (Lyophilized ) and Canine parvovirus (Liquid) vaccine, Inactivated 3. M/s. Zoetis Limited, Canine Distemper-Adenovirus Type-2- Coronavirus- SVV Godown No. 1&2, Bldg. No. 12B, Parainfluenza-Parovirus Vaccine, Modified Live & Killed Prithvi Complex, Reti Bunder Road, Virus, Leptospira Canicola-Grppotyphosa- 18/02/2019 Kalher, Tah. Bhiwandi, Dist. Thane , Icterhaemorrhagiae-Pomona Bacterin Canine coronavirus Vaccine, Inactivated, I.P 4. M/s. Stallen South Asia Pvt Ltd., 6 th Floor, Matharu Arcade, Subhash Road, Vile Parle East, Mumbai , Newcastle Disease vaccine, Inactivated Combined Ranikhet, Infectious Bronchitis, Infectious Bursal and Avian Reovirus Vaccine, Inactivated Inactivated Avian Salmonellosis Vaccine I.P. Inactivated Mycoplasma synoviae vaccine SV /05/ M/s Hester Biosciences Limited., Village: Merda Adraj, Taluka: Kadi, District: Mehsana, Gujarat ,. Quadrivalent Live Attenuated Coccidiosis vaccine SVV /12/2019 Page 8 of 10

9 6. M/s Virbac Animal Health Pvt. Ltd., Freeze Dried Attenuated Canine Distemper, Adenovirus- SV Chamber No. 6-C, 2nd Floor, Bhanu Ice & Cold 2, Parvovirus, Parainfluenzae attenuated virus vaccine & Storage Pvt. Ltd., Plot No. D-202, TTC Industrial Leptospira Vaccine Inactivated, I.P 14/03/2020 Area, Turbhe (Thane Zone 7), MIDC, Navi Mumbai , Maharashtra,. Rabies Veterinary Vaccine, Inactivated (Cell Culture), I.P. single dose Rabies Veterinary Vaccine, Inactivated (Cell Culture), I.P. Ten dose Combined Canine Distemper Canine Adenovirus-Type-2 and Canine Parvovirus Vaccine with Diluent Freeze dried attenuated vaccine for parentral use in Cats with diluent 7. M/s. Zoetis Limited, Godown No. 1&2, Bldg. No. 12B, Prithvi Complex, Reti Bunder Road, Kalher, Tah. Bhiwandi, Dist. Thane , 8. M/s Sanofi Synthelabo () Pvt. Ltd., City Link Warehousing Complex, Bldg No. A-4, Gala No.. 6&7, S.No. 120,121, Mumbai Nasik Highway vadpae Village, Tal:Bhiwandi-16, Dist: Thane Zone 5, 9. M/s Panav Bio-Tech 70, Ground Floor,Pvt No.-B-6, Najafgarh Road Industrial Area, New Delhi Marek s Disease Vaccine, Live, I.P Mycoplasma Gallisepticum Bacterin, Vaccine, Inactivated Marek s Disease Vaccine, Live, I.P. (Serotypes 3) Equine Rhinopneumonitis Vaccine, Killed Virus (Pneumabort-K +1b) Reo virus Vaccine, Inactivated, I.P Bursal Disease Vaccine, Live Virus Newcastle Disease vaccine, Live, IP Himmvac Hog Cholera (T/C) Vaccine Page 9 of 10 SVV /01/2020. SVV /02/2018 SVV valid upto 07/09/2020

10 10. M/s Hipra Pvt. Ltd. Infectious Brusal Disease Vaccine,Live I.P.(CH/80 Live SVV M No. 1/0361, First Floor, C/O Reality Ware Housing Pvt. Ltd. Cloned Vaccine) Gut No. 1337/1,old gut no. 2323/1 Wagholi , Tal. Haveli. Dist Pune, 11. M/s. Zoetis Limited, Godown No. 1&2, Bldg. No. 12B, Prithvi Complex, Reti Bunder Road, Kalher, Tah. Bhiwandi, Dist. Thane ,. Feline Rhinotracheitis-Calici- Panleukopenia- Vaccine, Modified Live Virus SVV-4-15 valid up to 18/02/2019 Page 10 of 10

Status of Import License (Form 10) of Recombinant Products, Human and Veterinary Vaccines issued from 30/04/2016 to 20/12/2016

Status of Import License (Form 10) of Recombinant Products, Human and Veterinary Vaccines issued from 30/04/2016 to 20/12/2016 RECOMBINANT PRODUCTS S. No. Firm Name of Formulation Import License No. &